October 1, 2014 — Hospira Inc. has received a warning letter from the U.S. Food and Drug Administration (FDA) after an inspection of an Australian manufacturing plant discovered visible particles in an injectable drug.
Hospira reported the letter in a regulatory filing with the Securities and Exchange Commission (SEC).
The FDA identified “significant violations” of good manufacturing practices at a facility in Mulgrave, Victoria in February and March. The FDA is not restricting production or exports into the United States, but they are asking Hospira to fix the problems.
Inspectors found that Hospira took “no effective corrective action” after repeatedly finding foreign matter (specifically, crystal particles) in carboplatin, an injection chemotherapy drug.
In May 2012, Hospira was notified of visible particles in the finished drug. In September 2012, a customer complained about crystal-like particles in carboplatin. The investigation also reported fiber-like particles.
It took Hospira 15 months to confirm the problem, and it was not until March 2014 that Hospira issued a “Dear Healthcare Provider” letter recommending visual inspection of the product before use and a filter before administration.
The FDA warned:
“Despite the investigational efforts from 2012 to 2014, your firm has not implemented adequate corrective action related to the presence of crystal particles in your carboplatin injection drug. We remain concerned that crystal particles are intermittently observed in reserve samples.”
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